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ACTIVE PHARMACEUTICAL INGREDIENT QUALITY ASSESSMENT&nbsp;

This article was originally published in The Gold Sheet

15 Dec 2005

News

The Gold Sheet

Executive Summary

...will be supported by a more unified guidance effort as FDA strives to ensure that the benefits of its quality initiative reach into the API world. The agency and industry are debating what quality by design means in the API context and whether an ICH effort is needed to better define drug substance development expectations and to leverage QbD knowledge internationally. Critical quality attributes are emerging as a potential focal point for API submissions in pursuit of a more flexible and improvement-friendly regulatory approach. Tightening the linkage between API and dosage form manufacturers is a challenge in reaching the desired state. FDA is bringing its foreign inspection program under the quality initiative umbrella and using Q7A as a GMP roadmap.